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  • Experience with a Novel, Automated, External Cerebrospinal Fluid Drainage Control Device

    Final Number:

    Christina Duffin; Jan M. Eckermann MD; Susan Schaufelberger NP; Robert E. Lieberson MD, FAANS, FACS; William J. Meyer MD, PhD; Tung T. Trang MD

    Study Design:
    Clinical Trial

    Subject Category:

    Meeting: Congress of Neurological Surgeons 2015 Annual Meeting

    Introduction: Most available lumbar drainage systems are functionally identical to the first gravity-fed device described in 1963. Although lumbar drainage is the standard of care for a variety of pathologies, complication rates are high, up to 40% in some series. Additionally, manually controlled lumbar drains are labor intensive and therefore costly. Gravity-independent, pump-regulated systems have been proposed, but adoption was limited by the risks associated with active CSF removal. We propose the use of a new gravity-fed system that is microprocessor controlled, programmable, and prevents over- or under-drainage. It should improve patient safety and lower treatment costs.

    Methods: Thirty-five consecutive patients requiring external lumbar drainage were treated using the FlowSafeTM system (BeckerSmith Medical, Irvine, CA).

    Results: Nineteen men and 16 women, average age 42.6 years, were drained for a mean of 93 hours (range 24 to 144). Drainage rates averaged 8.0 ml/hour (range 5 to 15). A single dose of antibiotics was used in 24 patients. Eleven received antibiotics for 48 to 144 hours. Diagnoses included skull base surgery (18), spontaneous and traumatic CSF fistulas (7), unintentional durotomy (7), normal pressure hydrocephalus (2), and intracranial hypertension due to meningitis (1). Set up times were minimal. Manual interventions, to regulate flow, were not required. There were no mechanical failures. Two individuals (6%) reported headache. Drainage was temporarily discontinued in one and the rate was decreased in the other. In both, headaches resolved promptly. No other complications were observed.

    Conclusions: The system proved convenient, safe and effective. Our complication rate was lower than in published series for current manual systems. Manual interventions were not required. With this system, ICU level care will not be necessary for many patients. Larger trials are needed, and the efficacy should be evaluated in patients with other diagnoses, including those undergoing aortic surgery.

    Patient Care: The FlowSafe device will improve patient care by providing an effective and safe method of cerebrospinal drainage in a more cost-saving manner than achieved with automated systems.

    Learning Objectives: By the conclusion of this session, participants should be able to: (1) describe the available CSF drainage systems; (2) discuss the indications for, efficacy of, and safety of cerebrospinal drainage; and (3) describe the cost-savings achieved with automated systems.


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